Study on the effectiveness of a treatment with statine in reducing the morbility and cardiovascular mortality in patients with moderate-strict renal insufficiency. - ND
- Conditions
- patients with moderate-strict renal insufficiencyMedDRA version: 6.1Level: PTClassification code 10038474
- Registration Number
- EUCTR2005-005155-18-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Patients of age 18-80 years, with moderated light renal insufficiency, identified from a VFG calculated with formula of Cockcoft and Gault between the 60 and 20 ml/min.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients for which the cardiovascular risk is much elevated 40 . Patients already in treatment with statine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Secondary Objective: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, constituted from mortality and cardiovascular morbility.;Primary end point(s): A composite of serious cardiovascular events infarct, ictus, intestinal infarct, thrombosis renal arteries and cardiovascular mortality.
- Secondary Outcome Measures
Name Time Method